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Cortex Manufacturing, Inc.
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FLEXIMARC, MODEL CM-0.9-2-10-GG-L is an FDA 510(k)-cleared medical device (K100267) manufactured by Cortex Manufacturing, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2010. Regulation: 8.